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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 January 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-dimethylhept-5-enal
EC Number:
203-427-2
EC Name:
2,6-dimethylhept-5-enal
Cas Number:
106-72-9
Molecular formula:
C9H16O
IUPAC Name:
2,6-dimethylhept-5-enal
impurity 1
Chemical structure
Reference substance name:
6-methylhept-5-en-2-one
EC Number:
203-816-7
EC Name:
6-methylhept-5-en-2-one
Cas Number:
110-93-0
Molecular formula:
C8H14O
IUPAC Name:
6-methylhept-5-en-2-one
impurity 2
Chemical structure
Reference substance name:
(1R,2R,5R)-2-methyl-5-(prop-1-en-2-yl)cyclopentan-1-ol
Cas Number:
83059-39-6
Molecular formula:
C9H16O
IUPAC Name:
(1R,2R,5R)-2-methyl-5-(prop-1-en-2-yl)cyclopentan-1-ol
impurity 3
Chemical structure
Reference substance name:
(1R,2S,5R)-2-methyl-5-(prop-1-en-2-yl)cyclopentan-1-ol
Cas Number:
83026-65-7
Molecular formula:
C9H16O
IUPAC Name:
(1R,2S,5R)-2-methyl-5-(prop-1-en-2-yl)cyclopentan-1-ol
impurity 4
Reference substance name:
2-(3-methylcyclopent-2-en-1-yl)propan-2-ol
Molecular formula:
C9H16O
IUPAC Name:
2-(3-methylcyclopent-2-en-1-yl)propan-2-ol
Test material form:
liquid
Specific details on test material used for the study:
Identification: Melonal
Appearance: Colourless to pale yellow liquid
Batch: PE00166491

Test animals / tissue source

Species:
other: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbisch, The Netherlands), where the eyes were excised by a slaughthouse employee as soon as possible after slaughter.
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbisch, The Netherlands), where the eyes were excised by a slaughthouse employee as soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions. The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded. The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium (Life Technologies, Bleiswijk, The Netherlands) containing 1% (v/v) L-glutamine (Life Technologies) and 1% (v/v) Foetal Bovine Serum (Life Technologies)).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
9.5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No category. Since Melonal induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.
Executive summary:

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.The mean in vitro irritancy score of the positive control (Ethanol) was 43 and was within two standard deviations of the current historical positive control mean (Appendix 3,Table 6). It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Melonal induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 9.5 after 10 minutes of treatment.

Since Melonal induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.